Introduction
Conception (or concept development) is where the selected ideas are fleshed out into viable concepts. This stage involves research to define the product’s intended purpose, features and functionality at a high level. Creating a clear and detailed concept grounded in evidence is crucial to guide further development.
What is concept development?
Conception bridges the gaps between ideation and formal research phases of the development lifecycle. Promising ideas are investigated further to determine whether they could realistically become a product.
This is also an essential phase for terminating ideas that do not hold promise.
Investigations typically build on the evidence gathered during the ideation phase. They become more targeted towards identifying high-level requirements and highlighting potential challenges or barriers to a successful product launch.
The main activities in the conception phase centre on desk research, user research and exploratory experimental studies.
- Desk research: Technology landscaping of clinical, technical, IP, competitive, market, and funding landscapes forms the basis of defining design specifications as part of the conception phase. Researching regulatory and market access requirements is critical for refining a product concept. These activities may start early in ideation and become more focused through the development lifecycle.
- User research: In-depth consultations, visits to clinical settings, surveys, and interviews are all helpful user research tools during the conception phase. The goal is determining whether the product concept(s) will meet user needs and expectations.
- Risk management is a process that occurs throughout the medical device lifecycle, usually beginning in the conception phase. Early-stage risk management activities include risk analysis and assessment. Beginning risk management early helps identify harms and hazards that could hamper the innovation later in the development lifecycle.
- Experimental studies: These studies vary widely depending on the technology underpinning the medical device innovation. They may include in vitro, in vivo, or in silico experiments. Highly disruptive breakthrough medical devices may require early-stage experimental research to establish their scientific validity. Creating prototypes is also a key part of the conception phase, as they allow for early testing and iterative improvements.
Intended purpose development
The main output from the conception phase is a draft of the intended purpose statement. Innovators often develop several versions of the intended purpose to explore further in the research and feasibility phase.
Developing an intended purpose statement for medical devices is a critical process that ensures the device is clearly and accurately described for regulatory approval, clinical use, and market placement. This statement forms the foundation for regulatory and health technology assessment (HTA) submissions and guides the device’s use and marketing claims.
The intended purpose is the most essential document for a medical device. To describe the intended purpose, use clear, concise, and unambiguous language. Ensure the language aligns with regulatory standards and terminology and avoids unnecessary technical jargon.
The data gathered during the conception phase develops draft intended purpose statements. These statements are further researched and refined until enough evidence has been gathered to determine the product’s feasibility.
Resources
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Clinical Evaluation: A methodologically sound ongoing procedure to collect, appraise, and analyse clinical data about a medical device and to verify its safety and performance, including its clinical benefits. Also see Clinical Investigation.
Conception The initial phase of product development, during which an idea is generated and conceptualised into a feasible product design, considering market needs, technical feasibility, potential benefits, and risks.
Equivalency: Demonstrating that a new device is as safe and effective as an already marketed device by comparing its technical and functional characteristics.
Healthcare Professional: An individual trained and licensed to provide medical care, treatment, and advice to patients, encompassing a range of roles such as physicians, nurses, pharmacists, and allied health professionals.
Ideation: The creative process of generating, developing, and communicating new ideas.
Manufacturer: A legal entity that designs, produces, assembles, or labels a medical device with the intention of placing it on the market.
Medical Device: An instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software, material, or other similar or related article intended for diagnosis, prevention, monitoring, treatment, or alleviation of disease. Each regulatory authority has a formal definition of a medical device, which should be referred to for regulatory compliance.
Payer: An entity or organisation, such as an insurance company or government agency, responsible for reimbursing or funding healthcare expenses related to using health technologies.
Post-Market Surveillance (PMS): The proactive collection and review of experiences and data related to a device after it has been released onto the market to ensure continued safety and performance.
Predicate Device: An existing on-market device that provides a basis for comparison or reference in demonstrating substantial equivalence for regulatory purposes.
Regulation: The rules, laws, standards, and requirements set by regulatory authorities to ensure the safety, efficacy, and quality of devices intended for medical use.
Regulatory Authority: An official body overseeing and enforcing laws, regulations, and standards within a specific industry or sector to ensure compliance and protect public interests. Also known as a Regulatory Authority. Also see Competent Authority and Notified Body.
Regulatory Submission: The formal process of submitting documentation and data to regulatory authorities for review and approval to market or sell the device within a specific jurisdiction.
Reimbursement: The process of receiving payment from insurers, government health programs, or healthcare facilities for the use of medical devices in patient care.
Standard: A document that provides guidance, requirements, or specifications established by regulatory bodies, industry organisations, or international consensus groups.
State-of-the-art (SotA): The current knowledge or good practice acceptable in the medical devices industry.
Systematic Review: A structured and comprehensive synthesis of research studies that aims to identify, select, assess, and summarise the findings of all relevant individual studies on a particular topic.